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Moxonidine in Patients Undergoing Vascular Surgery

This study has been terminated.
(Study was stopped after pre-definied interim analysis because of no effects)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00244504
First Posted: October 26, 2005
Last Update Posted: November 10, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Basel, Switzerland
  Purpose
Investigating the perioperative effect of moxonidine. In a randomized double-blind fashion, patients undergoing vascular surgery will receive moxonidine 0.2 mg or placebo from the day before surgery until day 4 after surgery. Holter-EKG for 48 h, starting just before surgery. Repeated 12-lead EKG, measurements of Troponin I and BNP, clinical visitations, follow-up interviews at 6 and 12 months

Condition Intervention Phase
Cardiac Disease Vascular Surgery Drug: moxonidine Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effects of Small Doses of Moxonidine in Patients Undergoing Vascular Surgery

Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • over-all mortality [ Time Frame: 30 days and 12 months ]

Secondary Outcome Measures:
  • Ischemia detected by Holter-ECG ST alterations or troponin T elevation [ Time Frame: 7 days ]

Enrollment: 141
Study Start Date: November 2002
Study Completion Date: March 2006
Primary Completion Date: March 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: I
moxonidine group
Drug: moxonidine
moxonidine 0.2 mg/d starting the morning of surgery until day 4 after surgery
Other Name: Physiotens
Placebo Comparator: II
placebo group
Drug: moxonidine
moxonidine 0.2 mg/d starting the morning of surgery until day 4 after surgery
Other Name: Physiotens

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • abdominal aortic or peripheral vascular surgery

Exclusion Criteria:

  • unstable angina,
  • severe symptomatic heart failure (NYHA IV)
  • systolic blood pressure at rest < 100 mmHg
  • bradycardia (<50/min)
  • higher grade AV heart block
  • creatinine clearance < 30 ml/min
  • pregnancy
  • no consent
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00244504


Locations
Switzerland
University hospital
Basel, CH, Switzerland, 4000
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Miodrag Filipovic, PD Dr. University Hospital, Basel, Switzerland
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PD Dr. M. Filipovic, Co-Head of Cardiothoracic Anaesthesia
ClinicalTrials.gov Identifier: NCT00244504     History of Changes
Other Study ID Numbers: 158/01
First Submitted: October 25, 2005
First Posted: October 26, 2005
Last Update Posted: November 10, 2009
Last Verified: November 2009

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases
Moxonidine
Antihypertensive Agents